CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Read the official notice →- Date
- 2026-07-08
- Country
- United States
- Brand
- CareFusion
- Product
- BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL…
- Classification
- Class II
- Units
- Distributed Nationwide in the USA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More CareFusion recalls
- 2026-07-22
USCareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL)…
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
- 2026-07-01
- US
CareFusion 213, LLC recalls BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators,…
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner…
Non-Sterility: Due to presence of Aspergillus penicillioides.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile…
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA · DrugCareFusion 213, LLCNationwide inthe USA, as well as other foreign distribution.Official notice → - 2026-06-10
- US
CareFusion 303, Inc. recalls BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
FDA · DeviceCareFusion 303, Inc.US: Nationwide OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ,…Official notice → - 2026-05-13
- US
CareFusion 213, LLC recalls BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x…
Lack of assurance of Sterility: potential product contamination
Other drugs & medical recalls in the United States
- 2026-07-08
- US
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc.,…
Failed Impurities/Degradation Specifications
- US
- 2026-07-01
- US
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413,…
Potential for thrombus formation during prolonged use of the introducer.
FDA · DeviceAbiomed, Inc.Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA…Official notice → - US
Medline Industries, LP recalls Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK…
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA · DeviceMedline Industries, LPUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Boston Scientific Corporation recalls Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the state of OH.Official notice →